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Bryan Cave Leighton Paisner's Food and Beverage Law BlogWed, 09 Jan 2019 22:16:36 +0000en-UShourly1https://wordpress.org/?v=4.9.9Missouri Faces Challenge to Meat Labeling Lawhttps://bclpdigest.com/missouri-faces-challenge-to-meat-labeling-law/
https://bclpdigest.com/missouri-faces-challenge-to-meat-labeling-law/#respondWed, 09 Jan 2019 22:16:36 +0000https://bclpdigest.com/?p=3687Amid growing debate over food identity standards, Missouri has become the first state to directly regulate whether meat substitutes can be labeled as “meat.” In August, Missouri passed Mo. Rev. Stat. § 265.494(7), which makes it a crime to misrepresent a product as meat that is not derived from livestock or poultry. Violators can be imprisoned for up to one year and fined up to $1,000.

The law targets two types of products: plant-based meat and cell-cultured meat (CCM). Plant-based meat is made from ingredients like soy, tempeh, and jackfruit. As we previously explained, CCM is grown in a lab by replicating animal cells. As the CCM industry is just emerging, the law most immediately affects sellers of plant-based products. But the law shows that the Missouri legislature may have anticipated labeling issues in connection with CCM and wished to take action in advance of the forthcoming changes]]>

Amid growing debate over food identity standards, Missouri has become the first state to directly regulate whether meat substitutes can be labeled as “meat.” In August, Missouri passed Mo. Rev. Stat. § 265.494(7), which makes it a crime to misrepresent a product as meat that is not derived from livestock or poultry. Violators can be imprisoned for up to one year and fined up to $1,000.

The law targets two types of products: plant-based meat and cell-cultured meat (CCM). Plant-based meat is made from ingredients like soy, tempeh, and jackfruit. As we previously explained, CCM is grown in a lab by replicating animal cells. As the CCM industry is just emerging, the law most immediately affects sellers of plant-based products. But the law shows that the Missouri legislature may have anticipated labeling issues in connection with CCM and wished to take action in advance of the forthcoming changes to the market.

Already, though, the law is being challenged. Tofurky Company, a maker of plant-based meat products, and The Good Food Institute (GFI), a proponent of meat alternatives, have sued a class of all Missouri prosecutors who have enforcement power. Tofurky and GFI assert that the law criminalizes truthful speech and violates their First Amendment rights. Tofurky fears it may face prosecution for describing products as “veggie burgers,” “chorizo style sausages,” and “slow roasted chik’n.” Accordingly, it has asked the court to bar enforcement of the law until the suit is resolved.

In response, the State of Missouri—which intervened to defend the law’s constitutionality—argues that the meat labeling law “does not do what Tofurky fears it does.” Based on a filing in the litigation, the State’s position is that the law only prohibits false statements that confuse customers into believing meat substitutes are traditional meat products. Such false and misleading commercial speech is not protected under the First Amendment. The State says that sellers like Tofurky that use modifiers such as “veggie,” “vegan,” and “plant-based” on their labels are not in danger of prosecution.

This approach might be too lenient for some in the conventional meat industry. The U.S. Cattlemen Association, for example, has argued that substitutes should not be able to use “meat” and “beef” in their labeling.

Unless and until the court rules otherwise, products are required to comply with the law. The Missouri Department of Agriculture is in charge of administering the law, and starting this month, it may begin referring suspected violations to county prosecutors and the attorney general. The Department has issued guidance indicating that it will not refer products whose labels contain the following:

Prominent statement on the front of the package, immediately before or immediately after the product name, that the product is “plant-based,” “veggie,” “lab-grown,” “lab- created,” or a comparable qualifier; and

Prominent statement on the package that the product is “made from plants,” “grown in a lab,” or a comparable disclosure

We will continue monitoring the case and provide updates on further developments.

]]>https://bclpdigest.com/missouri-faces-challenge-to-meat-labeling-law/feed/0FDA Provides Guidance for New Nutrition and Supplement Facts Labelshttps://bclpdigest.com/fda-provides-guidance-for-new-nutrition-and-supplement-facts-labels/
https://bclpdigest.com/fda-provides-guidance-for-new-nutrition-and-supplement-facts-labels/#respondFri, 09 Nov 2018 18:03:19 +0000https://bclpdigest.com/?p=3682On November 5, the FDA released non-binding guidance intended to answer questions related to Nutrition Facts and Supplement Facts Label and Serving Size final rules. As we previously reported, the rules were finalized in May 2016 and initially set a general compliance date of July 2018. The FDA has extended that deadline to January 1, 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales have an extra year to comply, until January 1, 2021.

The May 2016 rules require a revamped Nutrition Facts label that, among other things,

On November 5, the FDA released non-binding guidance intended to answer questions related to Nutrition Facts and Supplement Facts Label and Serving Size final rules. As we previously reported, the rules were finalized in May 2016 and initially set a general compliance date of July 2018. The FDA has extended that deadline to January 1, 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales have an extra year to comply, until January 1, 2021.

The May 2016 rules require a revamped Nutrition Facts label that, among other things,

Updates serving sizes to reflect the amounts that people are actually eating. For packages that are between one and two servings, the calories and other nutrients will be required to be labeled as one serving because people typically consume it in one sitting.

In connection with the May 2016 rules, the FDA provided the following example illustrating what’s different about the new Nutrition Facts label:

The first addresses questions on general compliance with the May 2016 rules.

The second section includes detailed questions and answers on issues related to “added sugars” on nutrition labels. For example, the guidance addresses when certain fruits and vegetable components will count as “added sugars” for purposes of labeling.

The third (very brief) section includes one question and answer addressing formatting questions for nutrition labels.

Finally, the fourth section includes detailed questions and answers discussing when nutrition labels must include the specific amount of a vitamin or mineral. Generally, when a vitamin or mineral needs to be listed on the label depends on the RDI for that specific vitamin or mineral.

]]>https://bclpdigest.com/fda-provides-guidance-for-new-nutrition-and-supplement-facts-labels/feed/0Missouri Alcohol Retailers no longer Tongue-Tied by Tied-House Restrictions on Advertisinghttps://bclpdigest.com/missouri-alcohol-retailers-no-longer-tongue-tied-by-tied-house-restrictions-on-advertising/
https://bclpdigest.com/missouri-alcohol-retailers-no-longer-tongue-tied-by-tied-house-restrictions-on-advertising/#respondMon, 22 Oct 2018 16:59:03 +0000https://bclpdigest.com/?p=3678Missouri tied-house law, which restricts dealings between suppliers, wholesalers and retailers, is currently in flux following a recent ruling by the US District Court for the Western District, which held that several of Missouri’s regulations pertaining to supplier advertising were unconstitutional. This pivotal opinion—which has wide-ranging implications for alcohol advertising in the state—was appealed to the 8th Circuit Court of Appeals on October 11, 2018 and has garnered widespread attention in the industry. The case raises economic and practical issues for retailers and significant legal and policy issues for state regulators.

In June, 2018 the District Court struck down three types of restrictions on alcohol advertising: 1) a restriction forbidding media advertising of price discounts—including restrictions prohibiting retailers from offering discounts on the purchase of beer or wine and from outside advertising of discounts on alcohol; 2) a restriction forbidding retailers from advertising prices below cost; and 3) a statute]]>

Missouri tied-house law, which restricts dealings between suppliers, wholesalers and retailers, is currently in flux following a recent ruling by the US District Court for the Western District, which held that several of Missouri’s regulations pertaining to supplier advertising were unconstitutional. This pivotal opinion—which has wide-ranging implications for alcohol advertising in the state—was appealed to the 8th Circuit Court of Appeals on October 11, 2018 and has garnered widespread attention in the industry. The case raises economic and practical issues for retailers and significant legal and policy issues for state regulators.

In June, 2018 the District Court struck down three types of restrictions on alcohol advertising: 1) a restriction forbidding media advertising of price discounts—including restrictions prohibiting retailers from offering discounts on the purchase of beer or wine and from outside advertising of discounts on alcohol; 2) a restriction forbidding retailers from advertising prices below cost; and 3) a statute prohibiting suppliers and wholesalers from providing any financial aid to retailers, including through advertising, with certain exceptions allowing suppliers or wholesalers to advertise on behalf of retailers under certain conditions.

The Court held that these restrictions did not directly advance the State’s interests in dissuading overconsumption of alcohol and combating underage drinking, and that the regulations were more extensive than necessary to further the government’s interest. Additionally, the Court found that the Missouri statute requiring wholesalers to list more than one retailer on an advertisement was unconstitutional because it compelled speech. The Court’s order enjoined the State from enforcing the aforementioned restrictions on advertising.

Just this week, the State appealed the Court’s ruling to the Eighth Circuit Court of Appeals. In the interim, Missouri cannot enforce regulations which previously restricted retailers’ advertisements/discounts and manufacturer/wholesaler advertisements on behalf of retailers. It remains to be seen how other courts in the State will interpret the contours of the Taylorruling. In the meantime, the Missouri Division of Alcohol and Tobacco Control has promulgated an emergency amendment to its regulations, which would allow “manufacturers of intoxicating liquor to offer consumer rebate coupons and advertise […] sales below cost.” The proposed amendment also expands the definition of the word “advertisement” to include “internet, email, texting, website, mobile applications… or any electronic means.” The practical effect of these developments remains to be seen, but until another Court weighs in on the matter, it appears that many of Missouri’s tied-house laws are effectively unenforceable as they relate to advertising by alcohol retailers.

]]>https://bclpdigest.com/missouri-alcohol-retailers-no-longer-tongue-tied-by-tied-house-restrictions-on-advertising/feed/0California Amends Slack Fill Lawhttps://bclpdigest.com/california-amends-slack-fill-law/
https://bclpdigest.com/california-amends-slack-fill-law/#respondWed, 03 Oct 2018 14:59:41 +0000https://bclpdigest.com/?p=3675Governor Jerry Brown recently signed into law Assembly Bill 2632, which amended California’s slack fill statute to create several exemptions. This amendment will be an additional hurdle to the plaintiff bar, which has been flooding the courts with slack fill related lawsuits in recent years. These lawsuits, typically filed as class actions, allege that product packaging is misleading to the extent it contains nonfunctional empty space, known as slack fill, which causes consumers to believe they are receiving more of the product than they actually are.

The new law, which will amend California Business and Professions Code Sections 12606 and 12606.2, includes the following key changes:

The amended law exempts packaging sold in a mode of commerce that “does not allow the consumer to view or handle the physical container or product.” It could be argued that this exempts online sales.

The amended law exempts product packaging that clearly]]>

Governor Jerry Brown recently signed into law Assembly Bill 2632, which amended California’s slack fill statute to create several exemptions. This amendment will be an additional hurdle to the plaintiff bar, which has been flooding the courts with slack fill related lawsuits in recent years. These lawsuits, typically filed as class actions, allege that product packaging is misleading to the extent it contains nonfunctional empty space, known as slack fill, which causes consumers to believe they are receiving more of the product than they actually are.

The new law, which will amend California Business and Professions Code Sections 12606 and 12606.2, includes the following key changes:

The amended law exempts packaging sold in a mode of commerce that “does not allow the consumer to view or handle the physical container or product.” It could be argued that this exempts online sales.

The amended law exempts product packaging that clearly and conspicuously depicts the product “fill line” on exterior packaging or the immediate product container if visible at point of sale.

Food containers are now exempt where “[t]he actual size of the product or immediate product container is clearly and conspicuously depicted on any side of the exterior packaging, excluding the bottom, accompanied by a clear and conspicuous disclosure that the depiction is the ‘actual size’ of the product or immediate product container” and “t]he dimensions of the product or immediate product container are visible through the exterior packaging.”

The new amendment comes in the wake of yet another defense victory in a slack fill decision. In Spacone v. Sanford, L.P., the U.S. District Court for the Central District of California recently denied class certification, holding that the plaintiff lacked sanding and could not satisfy the commonality and typicality requirements of Rule 23 of the Federal Rules of Civil Procedure. Spacone asserted “slack fill” claims against Sanford relating to his purchase of Krazy Glue, claiming that the space between the interior of the container and the inner tube of glue constituted nonfunctional slack fill, in violation of California Business and Professions Code Section 12606(b). Spacone’s case was doomed by his own deposition testimony, in which he denied having been “ripped off” and admitted he did not overpay for the Krazy Glue. Spacone’s only injury was that there was not enough glue in the package for him to complete his project, requiring him to return to the store to purchase a second tube. Notwithstanding Spacone’s conflicting self-serving declaration, which the court disregarded, the court found that his inconvenience did not constitute an economic injury, and therefore did not satisfy California’s statutory standing requirement.

]]>https://bclpdigest.com/california-amends-slack-fill-law/feed/0End of the Road for Mike and Ike Slack Fill Litigationhttps://bclpdigest.com/end-of-the-road-for-mike-and-ike-slack-fill-litigation/
https://bclpdigest.com/end-of-the-road-for-mike-and-ike-slack-fill-litigation/#respondFri, 17 Aug 2018 20:29:10 +0000https://bclpdigest.com/?p=3672In another victory for a candy manufacturer, a federal court in Missouri denied class certification earlier this month, effectively ending the plaintiff’s attempt to seek damages on a class-wide basis for all consumers of Hot Tamales and Mike and Ike candies.

The lawsuit, White v. Just Born, alleged that boxes of the candy were underfilled, leaving unusable empty space, known as “slack fill,” that deceived the consumer into thinking he was receiving more candy than was actually in the package. The plaintiff sought certification of a Missouri class, and two multi-state unjust enrichment classes, on the theory that the actual value of the candy was less than the consumers paid for it.

The court declined to certify all three classes, ruling that proving class-wide violation of Missouri’s Merchandising Practices Act “will involve predominantly individual inquiries as to whether each class member purchased the candy.” Because most consumers purchase this type]]>

In another victory for a candy manufacturer, a federal court in Missouri denied class certification earlier this month, effectively ending the plaintiff’s attempt to seek damages on a class-wide basis for all consumers of Hot Tamales and Mike and Ike candies.

The lawsuit, White v. Just Born, alleged that boxes of the candy were underfilled, leaving unusable empty space, known as “slack fill,” that deceived the consumer into thinking he was receiving more candy than was actually in the package. The plaintiff sought certification of a Missouri class, and two multi-state unjust enrichment classes, on the theory that the actual value of the candy was less than the consumers paid for it.

The court declined to certify all three classes, ruling that proving class-wide violation of Missouri’s Merchandising Practices Act “will involve predominantly individual inquiries as to whether each class member purchased the candy.” Because most consumers purchase this type of product from a third-party retailer rather than from the manufacturer – at a movie theater, for example – there is no master list to provide common proof of purchase. Each class member will need to demonstrate his own individualized purchase, which makes the class unascertainable.

Furthermore, the court found that the “litigation would be dominated by individual inquiries into whether each class member was deceived by any slack-fill in a box before purchasing it. In other words, it would be dominated by causation and knowledge.” Because “an individual who knew what he was getting before he purchased one of the candy boxes but chose to purchase it anyway cannot establish that Just Born’s retention of the purported benefit was unjust[,]” inquiries into each class member’s knowledge prior to purchase would also predominate.

The court also denied certification on standing grounds, holding that “White cannot represent a class that includes persons who purchased the candy despite knowing how much slack-fill would be in each box” because such a class would include members who lack standing to bring such a claim.

The decision is a significant victory for Just Born and other food manufacturers defending similar claims which often advance past the pleading stage, but are unlikely to satisfy the rigorous standards of class certification.

]]>https://bclpdigest.com/end-of-the-road-for-mike-and-ike-slack-fill-litigation/feed/0FDA to Modernize Food Identity Standards, Starting With Dairy Productshttps://bclpdigest.com/fda-to-modernize-food-identity-standards-starting-with-dairy-products/
https://bclpdigest.com/fda-to-modernize-food-identity-standards-starting-with-dairy-products/#respondFri, 03 Aug 2018 21:05:38 +0000https://bclpdigest.com/?p=3669FDA Commissioner Scott Gottlieb has announced that the FDA is undertaking a comprehensive review of food standards of identity to ensure food labels are truthful and not misleading. No doubt that for some this announcement is a long overdue response to rapidly evolving innovation in the food production sector that continues to challenge standards for truthful and non-misleading food labeling.

The FDA intends to focus first on standards of identity for dairy products. In his statement, Gottlieb discusses the highly controversial topic regarding plant-based alternatives and the standard of identity for “milk,” e.g., soy, almond, etc. These plant-based alternatives “are not the food that has been standardized under the name ‘milk’ and which has been known to the American public as ‘milk’ long before the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was established,” Gottlieb says. He goes on to suggest that these plant-based products are creating]]>

FDA Commissioner Scott Gottlieb has announced that the FDA is undertaking a comprehensive review of food standards of identity to ensure food labels are truthful and not misleading. No doubt that for some this announcement is a long overdue response to rapidly evolving innovation in the food production sector that continues to challenge standards for truthful and non-misleading food labeling.

The FDA intends to focus first on standards of identity for dairy products. In his statement, Gottlieb discusses the highly controversial topic regarding plant-based alternatives and the standard of identity for “milk,” e.g., soy, almond, etc. These plant-based alternatives “are not the food that has been standardized under the name ‘milk’ and which has been known to the American public as ‘milk’ long before the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was established,” Gottlieb says. He goes on to suggest that these plant-based products are creating at least some confusion amongst consumers, especially related to the nutritional characteristics when compared to traditional milk. More specifically, the FDA seems focused on the nutritional implications of this mistaken identity and its potential effect on the healthy development of young children.

The FDA’s announcement marks a significant step for the FDA in modernizing standards of identity that have not been reviewed or revised in decades. The FDA intends to have a lengthy information gathering period including extensive opportunity for public comment. Ultimately, we may receive expect new guidance in the coming year specifically related to dairy product standards of identity. Other standards of identity that have seen an influx of alternative ingredients and formulations will likely be the target for the FDA’s next comment and review phase.

]]>https://bclpdigest.com/fda-to-modernize-food-identity-standards-starting-with-dairy-products/feed/0Coffee Defendants Likely To Seek Stay of Prop. 65 Action Following OEHHA’s Proposal to Exempt Coffee From Cancer Warning Requirementhttps://bclpdigest.com/coffee-defendants-likely-to-seek-stay-of-prop-65-action-following-oehhas-proposal-to-exempt-coffee-from-cancer-warning-requirement/
https://bclpdigest.com/coffee-defendants-likely-to-seek-stay-of-prop-65-action-following-oehhas-proposal-to-exempt-coffee-from-cancer-warning-requirement/#respondMon, 09 Jul 2018 17:25:05 +0000https://bclpdigest.com/?p=3666Defendants in the Proposition 65 case against Starbucks and numerous other coffee manufacturers and retailers have indicated that they intend to file a motion to stay that action following a proposal by the California agency that administers Prop. 65 to exempt coffee from the cancer warning requirement for certain types of exposures.

Judge Elihu Berle has issued an order in Council for Education and Research on Toxics v. Starbucks, et al., Los Angeles Superior Court Case No. BC435759, setting a hearing date on defendants’ contemplated request for a stay of the action for July 31 – the same day as the hearing on the plaintiff’s motion seeking a permanent injunction which could potentially result in defendants being required to sell their coffee products with a Prop. 65 warning in California.

Defendants in the Proposition 65 case against Starbucks and numerous other coffee manufacturers and retailers have indicated that they intend to file a motion to stay that action following a proposal by the California agency that administers Prop. 65 to exempt coffee from the cancer warning requirement for certain types of exposures.

Judge Elihu Berle has issued an order in Council for Education and Research on Toxics v. Starbucks, et al., Los Angeles Superior Court Case No. BC435759, setting a hearing date on defendants’ contemplated request for a stay of the action for July 31 – the same day as the hearing on the plaintiff’s motion seeking a permanent injunction which could potentially result in defendants being required to sell their coffee products with a Prop. 65 warning in California.

On June 15, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of proposed rulemaking to exempt coffee from the warning requirement when the Prop. 65 chemicals are created “as part of an inherent in the processes of roasting coffee beans and brewing coffee.” The notice further states that “[c]offee, a unique and complex chemical mixture made from the roasted seeds of the coffee plant, contains many different compounds, including carcinogens listed under Proposition 65, and anticarcinogens.”

According to OEHHA, the proposed regulation is based on extensive scientific evidence that drinking coffee has not been shown to increase the risk of cancer, and may reduce the risk of some types of cancer.

OEHHA notes that in a review of more than 1,000 studies, the World Health Organization’s International Agency for Research on Cancer (IARC) concluded that there is “inadequate evidence” that drinking coffee causes cancer. IARC found that coffee is associated with reduced risk for cancers of the liver and uterus, and does not cause cancers of the breast, pancreas and prostate. IARC also found that coffee drinking exhibits strong antioxidant effects related to reduced cancer risk.

While the proposed regulation would largely exempt coffee from Prop. 65 cancer warnings, it does not address exposures to listed chemicals that may be created in some way other than the process of roasting and brewing.

OEHHA’s proposed rulemaking follows a recent ruling by Judge Berle in the Starbucks case that the defendants did not establish that acrylamide in coffee was exempt from Prop. 65’s warning requirement under an exception for chemicals created “by cooking necessary to render the food palatable” or safe for consumption.

A public hearing on the proposed rulemaking is scheduled for August 16, and public comment will close on August 30. OEHHA encourages submission of comments through its website, at this link.

For questions or more information, contact a member of our Prop. 65 team.

]]>https://bclpdigest.com/coffee-defendants-likely-to-seek-stay-of-prop-65-action-following-oehhas-proposal-to-exempt-coffee-from-cancer-warning-requirement/feed/0Battle Heats Up Concerning Regulatory Jurisdiction Over Cultured Meat Productshttps://bclpdigest.com/battle-heats-up-concerning-regulatory-jurisdiction-over-cultured-meat-products/
https://bclpdigest.com/battle-heats-up-concerning-regulatory-jurisdiction-over-cultured-meat-products/#respondMon, 09 Jul 2018 17:15:33 +0000https://bclpdigest.com/?p=3664The next wave of emerging agricultural biotechnology is set for its first regulatory showdown. Cell-cultured meat (“CCM”) allows your steak to be grown in a lab by replicating animal cells. Some CCM products are even created using synthetic products derived from plants, insects, and other non-animal proteins. No matter the type of culture used, CCM products are created without animals born, raised, and slaughtered in the traditional manner. Advocates of this emerging industry have coined the term “clean meat,” but many in the conventional meat food industry feel it should not be called “meat” at all.

On February 9, 2018, the U.S. Cattlemen’s Association (“USCA”) filed a petition with the U.S. Department of Agriculture (“USDA”) requesting that USDA invoke its jurisdiction over CCM and mandate that such products not be allowed to use “meat” or “beef” in their labeling. Indeed, the USCA asserts that such terms should be associated]]>

The next wave of emerging agricultural biotechnology is set for its first regulatory showdown. Cell-cultured meat (“CCM”) allows your steak to be grown in a lab by replicating animal cells. Some CCM products are even created using synthetic products derived from plants, insects, and other non-animal proteins. No matter the type of culture used, CCM products are created without animals born, raised, and slaughtered in the traditional manner. Advocates of this emerging industry have coined the term “clean meat,” but many in the conventional meat food industry feel it should not be called “meat” at all.

On February 9, 2018, the U.S. Cattlemen’s Association (“USCA”) filed a petition with the U.S. Department of Agriculture (“USDA”) requesting that USDA invoke its jurisdiction over CCM and mandate that such products not be allowed to use “meat” or “beef” in their labeling. Indeed, the USCA asserts that such terms should be associated only with meat products “derived from the tissue or flesh of an animal harvested in the traditional manner.” As you might remember, this sounds very similar to the dispute the dairy industry waged over the term “milk.” What makes the CCM issue different is the timing of the dispute. The milk dispute came after a plethora of alternative milk products bombarded the market. Here, CCM products are realistically many years out from making an economical market entry.

The USCA had good reason to be the first to the table as CCM products will directly compete with conventional meat products the USCA has an interest in protecting. The request for USDA to invoke jurisdiction may also seem intuitive seeing that it already regulates the conventional meat food industry. But a quick look at how USDA regulates that industry demonstrates some possible hurdles in trying to exercise similar oversight of CCM production.

USDA

The USDA’s role in the regulation of meat and meat products stems from the Federal Meat Inspection Act (“FMIA”). FMIA defines a “meat food product” as:

“any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and which are exempted from definition as a meat food product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat food products.”

20 U.S.C. § 601(j) (emphasis added). Because CCM is grown from animal cells in a lab, the absence of a carcass seems to exclude CCM from FMIA’s definition. Even though there may be a derivative argument that CCM is properly regulated under FMIA, such oversight by USDA would look much different than its oversight of the conventional meat food industry. This is because USDA’s oversight under FMIA relates mainly to conditions and inspections of facilities involved in conventional meat food processing, i.e., slaughterhouses and meatpacking establishments, which are not utilized in the production of CCM products. Even the laboratories utilized for CCM production would require vastly different inspection guidelines than currently utilized under FMIA.

But despite USCA’s request, USDA has made no public statements or response to USCA’s petition. Meanwhile, it seems that another agency may be eyeing regulatory oversight of CCM.

FDA

In a surprising move, on June 15, 2018, the Food and Drug Administration (“FDA”) issued a noticeexpressing its interest in regulating the emerging CCM industry. The notice claims FDA jurisdiction over CCM under the Federal Food, Drug, and Cosmetic Act (“FFDCA”), and also touts its involvement in “rapidly evolving areas of technological innovation in food.” The FFDCA gives FDA jurisdiction over “food,” which includes “articles used for food” and “articles used for components of any such article.” The notice goes on to request comments on the issue and sets a public meeting to discuss the issues on July 12, 2018, in College Park, MD.

Although the jurisdictional trigger under the FFDCA seems to provide a colorable argument for FDA regulatory oversight of CCM products, industry groups on both sides of the dispute are sure to make this a hotly contested debate. The National Cattlemen’s Beef Association responded to the FDA’s notice with the following statement:

“NCBA looks forward to participating fully in the public meeting, and will use the opportunity to advocate for USDA oversight of lab-grown fake meat products. The Food and Drug Administration’s announcement disregards the authorities granted to USDA under the Federal Meat Inspection Act, as well as USDA’s significant scientific expertise and long-standing success in ensuring the safety of all meat and poultry products. Under the current regulatory framework, FDA plays an important role in terms of ensuring the safety of food additives used in meat, poultry, and egg products. All additives are initially evaluated for safety by FDA, but ultimately FSIS maintains primary jurisdiction.”

CCM advocates are pushing for FDA oversight in fear of USDA’s possible bias and protection of the conventional meat food industry. But such a move would not be without its challenges. The FDA has demonstrated its skepticism to alternative meat products with its cautious approach to one of the plant-based ingredients in Impossible Foods Inc.’s veggie burger. FDA recently delayed its regulatory decision on the food additive pending its continued safety review, and expects a final decision by July 23, 2018.

The possibility of some sort of dual role oversight by the USDA in conjunction with the FDA should also not be ruled out. So before the “meat” wars begin, the battle over regulatory jurisdiction must be sorted out.

]]>https://bclpdigest.com/battle-heats-up-concerning-regulatory-jurisdiction-over-cultured-meat-products/feed/0WARNING: New Proposition 65 “Clear and Reasonable Warning” Requirements Effective August 30, 2018https://bclpdigest.com/warning-new-proposition-65-clear-and-reasonable-warning-requirements-effective-august-30-2018/
https://bclpdigest.com/warning-new-proposition-65-clear-and-reasonable-warning-requirements-effective-august-30-2018/#respondThu, 14 Jun 2018 15:50:46 +0000http://bclpdigest.com/?p=3647Retailers and manufacturers should take steps now to ensure they are compliant with the new California Proposition 65 warning regulations that take effect on August 30, 2018.

Proposition 65 prohibits retailers and manufacturers from knowingly and intentionally exposing California consumers to a chemical known to the State of California to cause cancer or developmental or reproductive harm without first providing a “clear and reasonable warning.” (Cal. Health & Safety Code § 25249.6.) The revised regulations provide examples of “safe harbor” warnings that are deemed to be clear and reasonable under the new amendments. Notably, the use of the specific “safe harbor” warnings included in the regulations is not actually required. Retailers and manufacturers can use any clear and reasonable warning; however, using the examples provided ensures that the warning is sufficient.

As we previously reported, amendments to the warning regulations were approved in August 2016. The 2016 and the more]]>

Retailers and manufacturers should take steps now to ensure they are compliant with the new California Proposition 65 warning regulations that take effect on August 30, 2018.

Proposition 65 prohibits retailers and manufacturers from knowingly and intentionally exposing California consumers to a chemical known to the State of California to cause cancer or developmental or reproductive harm without first providing a “clear and reasonable warning.” (Cal. Health & Safety Code § 25249.6.) The revised regulations provide examples of “safe harbor” warnings that are deemed to be clear and reasonable under the new amendments. Notably, the use of the specific “safe harbor” warnings included in the regulations is not actually required. Retailers and manufacturers can use any clear and reasonable warning; however, using the examples provided ensures that the warning is sufficient.

As we previously reported, amendments to the warning regulations were approved in August 2016. The 2016 and the more recent November 2017 amendments change the form and content of the “safe harbor” warnings. The amendments also clarify who has responsibility for providing warnings.

For products manufactured before August 30, 2018, retailers and manufacturers can choose whether to rely on the current or new safe harbor warnings, as both are deemed sufficient under the regulations. Products manufactured after August 30, 2018, however, should include the new warning in order to ensure compliance. Parties to existing court-approved consent judgments can continue to provide warnings that comply with those orders.

New Content

The new regulations specify that safe harbor warnings for consumer products are required to say the product “can expose you to” a Proposition 65 chemical rather than saying the product “contains” the chemical.

The warnings must also include:

The name of at least one listed chemical that prompted the warning. If the product can cause exposure both to carcinogens and to reproductive toxicants, the warning should list at least one example of each. Importantly, the warning does not have to list all chemicals to which a product can cause exposure.

Most warnings must have a yellow triangular warning symbol. However, where the product label or shelf sign does not use the color yellow, the symbol may then be printed in black and white.

For certain warnings, where other consumer information is provided in a language other than English, the warning must also be provided in that language.

Warnings can still be provided on product labels, shelf tags, and shelf signs. Shelf signs should be product specific and posted at each point of display. For the first time, the regulation provides that warnings can also be received prior to purchase via electronic devices.

On-product warnings can use either the long or short versions discussed below.

Long Form Warnings

The regulations provide the following example of a safe harbor warning for an exposure to one or more chemicals that are either carcinogens or reproductive toxicants:

WARNING: This product can expose you to chemicals including [one or more listed chemical] which is [are] known to the State of California to cause cancer [or birth defects or other reproductive harm]. For more information, go to www.P65Warnings.ca.gov.

The regulations provide the following example of a safe harbor warning for exposures to one or more chemicals that are listed as both a carcinogen and a reproductive toxicant:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

The regulations provide the following example of a safe harbor warning for products that contain multiple listed chemicals, some of which are carcinogens and some of which are reproductive toxicants:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Food Warnings

For food products, the following warning must be set apart from other consumer information in a box on the product label. The regulations provide the example below:

WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals] which is [are] known to the State of California to cause [cancer and/or birth defects or other reproductive harm]. For more information, go to www.P65Warnings.ca.gov/food.

Note that the is not required for food warnings.

Short Form Warnings

Warnings on product labels can be shortened as follows, and do not require that a specific chemical be listed. For example:

Short-form warnings must be in a type size no smaller than other consumer information, and no smaller than 6-point type.

Internet Sales

For online sales, the new regulations require for the first time that a warning appear on the product display page, or through a clearly marked hyperlink using the word “WARNING,” or otherwise be provided prior to purchase – such as in a pop-up window triggered by entry of a California address. If a short-form warning is provided on the product, the same warning can be used online.

Warning Responsibilities Clarified for Manufacturers and Retailers

The new regulations seek to “minimize the burden” on retailers by putting the primary responsibility for providing warnings on manufacturers. Manufacturers can comply by labeling the product with a warning, or providing notice to retailers that specifically identifies the product that requires a warning and provides all warning materials. For the notice to be effective, receipt must be confirmed by the retailer electronically or in writing. The notice and confirmation must be renewed within six months after the regulations take effect, and annually thereafter.

Unless a manufacturer provides the notice described above, a retailer’s liability under the new regulations is limited to exposure from private label products, or where the retailer:

(1) knowingly introduces or causes a listed chemical to be created in the product,

(2) covers or obscures a warning,

(3) fails to post a warning provided by the manufacturer, or

(4) has actual knowledge of a potential exposure requiring a warning, and there is no other entity in the chain of distribution who is subject to Prop. 65 (has more than 10 employees). Actual knowledge will be presumed within 5 days of receipt of a 60-day notice.

To address the risk of retailer liability under issue (4), we recommend that retailers:

Monitor on a weekly basis any 60-day notices naming the retailer. Notices are in a searchable database available by clicking here.

Designate an email address, which employees will monitor daily, specifically for external Prop. 65 communications. An email address, such as CalProp65@yoururl.com, set up to receive Prop. 65 communications from suppliers will enable you to better monitor such emails from suppliers. The email responses can be set up to automatically include your policy regarding receipt and posting of warning materials from suppliers.

Determine which suppliers are not subject to Prop. 65, and maintain a list of the products sourced from these suppliers.

Have a plan in place to quickly decide whether to tender, warn, and or remove the product from sale. There will often not be enough time to submit the product for testing and evaluate it for potential exposure within 5 days after receipt of the notice.

The parties can still contractually allocate responsibility for providing a warning. Many retailers have revised their terms and conditions to state that they will not accept notice and warning materials from manufacturers, who will continue to have responsibility to label their products with any required warnings. Many retailers are also requiring vendors to provide an image of the warning suitable for posting online.

Industry-Specific Warnings

The new regulations impose additional specific requirements for certain products and industries, including restaurants, alcohol and furniture manufacturers.

Restaurants

The new regulations provide that the following warning be displayed in restaurants and other facilities that sell food and beverages for immediate consumption if the business determines that consumption of its food or beverage products will expose consumers to listed chemicals at levels above the safe harbor limits.

WARNING: Certain foods and beverages sold or served here can expose you to chemicals including acrylamide in many fried or baked foods, and mercury in fish, which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/restaurant

The warning must be provided using at least one of the following methods:

An 8 ½ by 11 inch sign, printed in no smaller than 28-point type, at each public entrance so that it is readable and conspicuous to customers;

A notice no smaller than 5 by 5 inches, printed in no smaller than 20-point type, placed at each point of sale so as to assure that it is readable and conspicuous; or

A warning on any menu or list describing food or beverages, in a type size no smaller than the largest type size used for the names of general menu items.

Alcoholic Beverages

The November 2017 amendments to the regulations require for the first time that restaurants that serve or sell alcoholic beverages post the following warning, which also must be posted where alcohol is sold at retail establishments.

The warning must be provided using at least one of the following methods:

An 8½ by 11 inch sign in no smaller than 22-point type, placed at eye level so that it is readable and conspicuous to customers as they enter the area where alcoholic beverages are served;

A notice or sign no smaller than 5 by 5 inches, in no smaller than 20-point type and enclosed in a box, placed at each retail point of sale or display so as to assure that it is readable and conspicuous.

On a menu or list of alcoholic beverages, or food or other beverages, served on the premises.

For alcoholic beverages sold or distributed through delivery services, the warning should be on the shipping container or package in a type size no smaller than the largest type size used for other consumer information on the product, and in no less than 8-point type.

Furniture Warnings

The new regulations also specify that in addition to a label warning on furniture products, furniture retailers must provide a notice at each public entrance or display, or printed on each receipt stating:

NOTICE: Some furniture products can expose you to chemicals known to the State of California to cause cancer or birth defects or other reproductive harm. Please check on-product label for warning information.

If posted at each public entrance or point of display, the notice should be no smaller than 8 ½ by 11 inches and in no smaller than 28-point type.

If printed on each receipt, the notice should be printed in no smaller than 12-point type.

Prepare For The New Requirements

All retailers and manufacturers who sell products in California should review their Proposition 65 compliance protocols to ensure that they continue to comply once the new regulations go into effect. This includes ensuring that warnings meet the new safe harbor requirements, and that all webpages accessible by California consumers contain the required warnings.

More information on our Proposition 65 Team and our relevant experience is available by clicking here. Please reach out to us for any advice or assistance in evaluating your company’s strategy for complying with the new warning requirements.

]]>https://bclpdigest.com/warning-new-proposition-65-clear-and-reasonable-warning-requirements-effective-august-30-2018/feed/0FDA Extends Date for Compliance with New Nutrition Facts Label; Menu Labeling Rules Take Effecthttps://bclpdigest.com/fda-extends-date-for-compliance-with-new-nutrition-facts-label-menu-labeling-rules-take-effect/
https://bclpdigest.com/fda-extends-date-for-compliance-with-new-nutrition-facts-label-menu-labeling-rules-take-effect/#respondFri, 18 May 2018 17:29:26 +0000http://bclpdigest.com/?p=3642The FDA has extended the date for compliance with the Nutrition Facts and Supplement Facts Label and Serving Size final rules. As we previously reported, the rules were finalized in May 2016 and initially set a general compliance date of July 26, 2018. Manufacturers with annual food sales of less than $10 million were given an additional year to comply.

The FDA has now issued a Federal Register notice extending the compliance dates by “approximately 1.5 years.”

Require mandatory declarations for “added sugars” in grams and as a percentage of Daily Value (% DV);

Update the list of declared nutrients. Disclosure of vitamin D and potassium will be required. Calcium and iron will continue to be required. Vitamins A and C will no longer be required but can be included]]>

Require mandatory declarations for “added sugars” in grams and as a percentage of Daily Value (% DV);

Update the list of declared nutrients. Disclosure of vitamin D and potassium will be required. Calcium and iron will continue to be required. Vitamins A and C will no longer be required but can be included on a voluntary basis.

Continue to retire “Total Fat,” Saturated Fat,” and “Trans Fat,” but no longer require “Calories from Fat,” since research shows the type of fat is more important than the amount.

Update daily values for nutrients like sodium, dietary fiber and vitamin D; and

The menu labeling rules require restaurants and similar retail food establishments that are part of a chain with 20 or more locations, doing business under the same name and offering substantially the same menu items, to provide calorie and nutrition information to consumers.

Covered establishments must disclose the number of calories contained in standard items on menus and menu boards. For self-service foods and foods on display, calories must be listed in close proximity and clearly associated with the standard menu item.

Businesses must also provide, upon request, the following written nutrition information for standard menu items:

total calories;

total fat;

saturated fat;

trans fat;

cholesterol;

sodium;

total carbohydrates;

sugars; fiber; and

protein.

In addition, two statements must be displayed—one indicating this written information is available upon request, and the other about daily calorie intake, indicating that 2,000 calories a day is used for general nutrition advice, but calorie needs vary.

The guidance includes an advisory of the FDA’s intent not to require nutrient declarations for calories from fat, “because the current science supports a view that the type of fat is more relevant to the risk of chronic disease than the overall caloric fat intake.”

The guidance also addresses concerns about the implementation of nutrition labeling, and provides expanded examples, including: